Medications & Supplements/Prescription Drugs

Aequita Pharmacy Semaglutide and Tirzepatide Recalled for Processing Controls

Agency Publication Date: August 1, 2025

Summary

Aequita Pharmacy is recalling 2,378 vials of Semaglutide + Cyanocobalamin and Tirzepatide + Niacinamide injectable solutions due to a lack of processing controls. These sterile multi-dose vials were distributed in Massachusetts and include all lots that have not yet expired. The recall was initiated because failures in processing controls can compromise the sterility of injectable medications, potentially leading to health complications for patients.

Risk

Injectable drugs produced without proper processing controls may be non-sterile, which poses a risk of infection or other serious adverse health events at the site of injection or throughout the body. No injuries or illnesses have been reported to date in connection with these products.

What You Should Do

This recall affects Semaglutide + Cyanocobalamin and Tirzepatide + Niacinamide sterile injectable solutions (multi-dose vials) produced by Aequita Pharmacy LLC of Kirkland, WA. The recall includes all lots currently within their expiration dates.
Check your medication labels for Semaglutide + Cyanocobalamin (strengths ranging from 0.22 mg to 2.67 mg) or Tirzepatide + Niacinamide (strengths ranging from 2.2 mg to 16.6 mg). See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Aequita Pharmacy directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Injectable Solution

Variants: 0.22 mg + 0.25mg/0.5 ml, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial

Model:

D-0553-2025

Lot Numbers:

All Lots within expiry

Quantity: 290 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 2.2 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial

Model:

D-0554-2025

Lot Numbers:

All Lots within expiry

Quantity: 236 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 4.4 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0555-2025

Lot Numbers:

All Lots within expiry

Quantity: 170 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 6.6 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0556-2025

Lot Numbers:

All Lots within expiry

Quantity: 160 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Injectable Solution

Variants: 8.8 mg + 1.0mg/0.5 ml, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0557-2025

Lot Numbers:

All Lots within expiry

Quantity: 139 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 11.24 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0558-2025

Lot Numbers:

All Lots within expiry

Quantity: 146 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 13.2 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0559-2025

Lot Numbers:

All Lots within expiry

Quantity: 143 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 16.6 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial

Model:

D-0560-2025

Lot Numbers:

All Lots within expiry

Quantity: 155 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 0.44 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0561-2025

Lot Numbers:

All Lots within expiry

Quantity: 221 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 0.88 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0562-2025

Lot Numbers:

All Lots within expiry

Quantity: 194 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 1.5 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0563-2025

Lot Numbers:

All Lots within expiry

Quantity: 190 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL

Variants: 2.21 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0564-2025

Lot Numbers:

All Lots within expiry

Quantity: 176 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 2.67 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0565-2025

Lot Numbers:

All Lots within expiry

Quantity: 158 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97292

Status: Active

Manufacturer: AEQUITA PHARMACY

Sold By: Aequita Pharmacy

Manufactured In: United States

Units Affected: 13 products (290 vials; 236 vials; 170 vials; 160 vials; 139 vials; 146 vials; 143 vials; 155 vials; 221 vials; 194 vials; 190 vials; 176 vials; 158 vials)

Distributed To: Massachusetts

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Semaglutide + Cyanocobalamin and Tirzepatide + Niacinamide sterile injectable solutions (multi-dose vials) produced by Aequita Pharmacy LLC of Kirkland, WA. The recall includes all lots currently within their expiration dates.

Check your medication labels for Semaglutide + Cyanocobalamin (strengths ranging from 0.22 mg to 2.67 mg) or Tirzepatide + Niacinamide (strengths ranging from 2.2 mg to 16.6 mg). See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Aequita Pharmacy directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Injectable Solution

Variants: 0.22 mg + 0.25mg/0.5 ml, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial

Model:

D-0553-2025

Lot Numbers:

All Lots within expiry

Quantity: 290 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 2.2 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial

Model:

D-0554-2025

Lot Numbers:

All Lots within expiry

Quantity: 236 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 4.4 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0555-2025

Lot Numbers:

All Lots within expiry

Quantity: 170 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 6.6 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0556-2025

Lot Numbers:

All Lots within expiry

Quantity: 160 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Injectable Solution

Variants: 8.8 mg + 1.0mg/0.5 ml, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0557-2025

Lot Numbers:

All Lots within expiry

Quantity: 139 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 11.24 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0558-2025

Lot Numbers:

All Lots within expiry

Quantity: 146 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 13.2 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0559-2025

Lot Numbers:

All Lots within expiry

Quantity: 143 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Injectable Solution

Variants: 16.6 mg + 1.0mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial

Model:

D-0560-2025

Lot Numbers:

All Lots within expiry

Quantity: 155 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 0.44 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0561-2025

Lot Numbers:

All Lots within expiry

Quantity: 221 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 0.88 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0562-2025

Lot Numbers:

All Lots within expiry

Quantity: 194 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 1.5 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0563-2025

Lot Numbers:

All Lots within expiry

Quantity: 190 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL

Variants: 2.21 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0564-2025

Lot Numbers:

All Lots within expiry

Quantity: 176 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Product: Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Injectable Solution

Variants: 2.67 mg + 0.25mg/0.5 mL, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial

Model:

D-0565-2025

Lot Numbers:

All Lots within expiry

Quantity: 158 vials. Refrigerate, Do not freeze. Aequita Pharmacy LLC, Kirkland, WA 98034.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97292

Status: Active

Manufacturer: AEQUITA PHARMACY

Sold By: Aequita Pharmacy

Manufactured In: United States

Units Affected: 13 products (290 vials; 236 vials; 170 vials; 160 vials; 139 vials; 146 vials; 143 vials; 155 vials; 221 vials; 194 vials; 190 vials; 176 vials; 158 vials)

Distributed To: Massachusetts